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Evaluation of the Effect and Tolerance of Preservative Free NAAGA on the Inflammatory Component and Symptoms of Dry Eye Syndrome in Allergic Conjunctivitis Patients

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ClinicalTrials.gov Identifier: NCT01203540
Recruitment Status : Completed
First Posted : September 16, 2010
Last Update Posted : January 31, 2012
Sponsor:
Collaborator:
Samil Pharmaceutical Co., Ltd.
Information provided by:
Laboratoires Thea

Brief Summary:

Multicentre, Double blind, Randomized, Comparative Study(comparing N-acetyl-aspartyl-glutamic acid(NAAGA) in Abak preservative free device versus SALINE in Abak preservative free device.

Evaluation of the effects and safety of NAABAK® through inflammation markers and symptoms in patients with allergic conjunctivitis and dry eye syndrome after 3 months treatment.

The patients will attend 4 visits.


Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: NAABAK eyedrops Drug: Saline eyedrops Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Evaluation of the Effect and Tolerance of Preservative Free NAAGA on the Inflammatory Component and Symptoms of Dry Eye Syndrome in Allergic Conjunctivitis Patients
Study Start Date : October 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

Arm Intervention/treatment
Experimental: Naaga in ABAK system Drug: NAABAK eyedrops
Placebo Comparator: Saline solution Drug: Saline eyedrops




Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 20 years old
  • Patients with dry eye syndrome in allergic conjunctivitis

Exclusion Criteria:

  • Severe dry eye syndrome
  • Severe ocular pathology

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01203540


Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Korea, Republic of
Seoul National University Boramae Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Laboratoires Thea
Samil Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier: NCT01203540     History of Changes
Other Study ID Numbers: NBKE_SNUBH&BM_01
LT0455-IST-01/10
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Conjunctivitis
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Lacrimal Apparatus Diseases
Keratoconjunctivitis
Keratitis
Corneal Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ophthalmic Solutions
Pharmaceutical Solutions